510(k) K024100
K024100 is an FDA 510(k) premarket notification submitted by Theratech, Inc. for the device "IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND". The FDA issued a decision of Substantially Equivalent on February 25, 2003. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Theratech, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2003
- Date Received
- December 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interferential Current Therapy
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type